Hydralazine Hydrochloride

ANDA 89097, held by Pliva. Hydralazine Hydrochloride.

As of Nov 15, 2026, ANDA 89097 (Hydralazine Hydrochloride), held by Pliva, was first approved by FDA on Dec 18, 1985, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 18, 1985
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 18, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydralazine Hydrochloride10MG · tablet;oral	Hydralazine Hydrochloride	Rx

All 11 submissions, including labeling and manufacturing supplements


Sep 11, 2014	Supplement 33Manufacturing	Approved	None posted
Jan 29, 2013	Supplement 34Labeling · Standard review	Approved	None posted
Nov 1, 2010	Supplement 23Labeling	Approved	None posted
Oct 11, 2001	Supplement 8Labeling	Approved	None posted
Jun 6, 2001	Supplement 6Manufacturing	Approved	None posted
May 29, 2001	Supplement 7Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 5Manufacturing	Approved	None posted
May 11, 1994	Supplement 4Manufacturing	Approved	None posted
Feb 24, 1992	Supplement 3Manufacturing	Approved	None posted
Apr 23, 1987	Supplement 1Manufacturing	Approved	None posted
Dec 18, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 89097
Drugs@FDA: Overview at FDA
Company: PLIVA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters